Overview of the licence application process for a cannabis drug licence

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Who’s this for

Use the content in these pages to apply for a cannabis drug licence. For other licences, refer to:

What’s a drug containing cannabis

A drug containing cannabis is any cannabis that is produced, packaged, labelled, and sold or distributed as a drug. This includes synthesized cannabis. The Cannabis Regulations define “drug” as any substance or mixture of substances manufactured, sold or represented for use in:

A drug containing cannabis can only have health claims if it has received a Drug Identification Number (DIN) and a Notice of Compliance (NOC).  If you want more information about this, refer to Health products containing cannabis or for use with cannabis.

In most cases, a drug establishment licence will also be required to conduct activities involving drugs containing cannabis. Refer to the Guidance on drug establishment licences to help understand and comply with Part C, Division 1A of the Food and Drug Regulations with regards to drug establishment licence requirements.

A drug containing cannabis is different from cannabis for medical purposes. If you want to sell cannabis products (e.g., dried cannabis, extracts, edibles or topicals) to registered clients for medical purposes, you need a sale for medical purposes licence, not a cannabis drug licence. Refer to the Application requirements for cannabis cultivation, processing and medical sales licences.

Foreword and disclaimer

Foreword

The Cannabis Act sets out that an applicant must file a licence application in the form and manner set by the Minister of Health, and include all the required information. These pages set out:

Under the Cannabis Act, Health Canada may require more information to process your licence application. If you don’t submit the information requested, the Minister may refuse to consider your application.

Disclaimer

You need to read these pages along with the Cannabis Act and the Cannabis Regulations. If there are differences between these pages and the Cannabis Act and the Cannabis Regulations, the Act and the Regulations are correct. If there are differences between the Cannabis Tracking and Licensing System (CTLS) and these pages, these pages are correct.

Health Canada’s CTLS is a Secure Web Portal and a single point of access for licence application submissions. You can access the CTLS directly at Health Canada’s Secure Web Portal. You should familiarize yourself with the use of this system and should refer to the CTLS Getting Started Guide for more information.

Licence application process

Important: You can only start your authorized cannabis activities after you’ve received your initial cannabis drug licence from Health Canada.

When starting the application process, Before you start applying for a licence has more information about what you should consider before applying. It may also be helpful to use the application checklist that can guide you through this process.

Figure 1 provides an overview of the licence application process and the things you need to do as an applicant.

Figure 1: Overview of licence application process

Figure 1: Diagram of the licence application process. Described under the heading Licence application process: key steps.

Licence application process: Key steps

1. The key steps you need to do before you start applying for a licence are to:

  1. Determine if you require a licence
  2. Prepare your site and identify people
  3. Prepare your information

2. The key steps you need to do when you apply for a licence are to:

  1. Create an individual account in the CTLS
  2. Create a licence application in the CTLS
  3. Submit your licence application in the CTLS

3. The key steps after you’ve submitted your licence application are:

  1. Health Canada processes your information
  2. You need to respond to information requests from Health Canada
  3. Health Canada makes a decision on your licence application

Application checklists

The checklist is a tool that can guide you through the licence application process. It summarizes the key tasks:

The checklist contains links to the sections where you can find more information.

Health Canada recommends using a document naming convention for all the information you have to submit. We can process your application more efficiently when you follow this document naming convention. It generally follows this layout:

“MainCategory”_APP-#_”SubCategory”_”YYYY-MM-DD”.”PDF”

Section 1:  Before you apply

Section 2:  Information to prepare

Important: If you’ve reached the upload limit of 5 documents in the CTLS, combine similar documents together. If you have any questions or need further instructions, email sp-licensing-cannabis-licences-sp@hc-sc.gc.ca. The subject line should be “Document upload limit for APP #”.

Section 3: Create a licence application

Section 4: Submit your information in the CTLS

Submit your application

Contact us

For questions related to a specific licence application, contact Health Canada by email at sp-licensing-cannabis-licences-sp@hc-sc.gc.ca. Include your Application ID found in the CTLS. The subject line should be, "Questions about APP #".

For questions about the CTLS, contact Health Canada by email at ctls-sscdl@hc-sc.gc.ca or by phone at 1-866-337-7705 (toll free).

For general questions, contact Health Canada by email at cannabis@hc-sc.gc.ca or by phone at 1-866-337-7705 (toll free).

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